Randomised studies in general practice: how to integrate the electronic patient record

Abstract

The 'randomised database study' strategy was first proposed in 1997, with the aim of combining the generalisability of observational database studies based on electronic patient records (EPRs) with the validity of randomised clinical trials (RCTs). The key feature was to randomly assign treatments and to use routine care data, as available in the observational database, for patient identification and follow-up. To our knowledge, however, the idea of the randomised database study has not been implemented yet.The conduct of a randomised study in an observational database requires adjustments to methods of medical information processing in the general practice. We developed a software system that facilitates the conduct of an RCT with observational databases based on EPRs. It identifies eligible subjects and presents them one by one to the physician once their EPR is accessed. The general practitioner can then start an interactive recruitment process; after completion, the computer randomises the patients. Follow-up is documented by normal routine care in the EPR.Although the randomised database study has many methodological advantages, it has never been tested. Our software system is meant as a tool to implement and facilitate evaluation of the randomised database approach.

A clinical trial alert tool to recruit large patient samples and assess selection bias in general practice research

“…To the best of our knowledge, this is the first study to implement and evaluate such a tool in a primary care setting in Germany. Worldwide, only few trials have reported the successful implementation of similar electronic tools [14,15]. While the CTA infrastructure helped to correctly identify a large population at risk with a minimal workload for the practice staff, the staff in nearly all practices missed the target to enrol 200 patients.…”

“…Our system is the first to support the practice staff in both identifying and surveying eligible patients during daily practice while recording pseudonymised data about the target population in order to monitor selection bias. In a study conducted in the Netherlands [14], the research team used an interactive reminder tool similar to the one described here to inform the GP when an eligible patient was selected by EPR and should be asked to participate in the study. However, eligible patients needed to be selected and marked in the EPR prior to study begin.…”